Medical Device Archive

Thursday, 12, March, 2026 / Published in China, Medical Device, News

China Seeks Comments on Draft 2026 Class III Clinical Trial Approval Catalogue

On February 3, 2026, the Center for Medical Device Evaluation (CMDE) released the “Catalogue of Class III Medical Devices Requiring…

Monday, 2, March, 2026 / Published in China, Medical Device, News

China NMPA Issues 2026 Medical Device Industry Standards Development and Revision Plan

On February 11, 2026, the National Medical Products Administration (NMPA) published “Notice on Issuing the 2026 Medical Device Industry Standards…

Monday, 2, March, 2026 / Published in China, Medical Device, News

China CMDE Releases 2026 Revision Guideline for Aesthetic HA Fillers

On February 6, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) issued “Announcement on Releasing the…

Thursday, 5, February, 2026 / Published in China, Medical Device, News

China Seeks Comments on Draft 2026 Class III Clinical Trial Approval Catalogue

On February 3, 2026, the Center for Medical Device Evaluation (CMDE) released the “Catalogue of Class III Medical Devices Requiring…

Thursday, 29, January, 2026 / Published in China, Medical Device, News

China NMPA Clears 104 Innovative Medical Devices for Special Review in 2025

In 2025, China’s National Medical Products Administration (NMPA), through its Center for Medical Device Evaluation (CMDE), released 12 batches of…

Wednesday, 28, January, 2026 / Published in China, Medical Device, News

China’s GB 4824-2025 Standard Approaches Enforcement, Expanding EMC Requirements

On March 1, 2026, “GB 4824-2025” will enter into force, formally replacing “GB 4824-2019.” Issued on February 28, 2025, by…

Wednesday, 21, January, 2026 / Published in China, Medical Device, News

China’s NMPA Updates Medical Device Classification Catalogue, Affecting 31 Categories

On January 4, 2026, China’s National Medical Products Administration (NMPA) issued “Announcement on Adjusting Certain Contents of the Medical Device…

Medical professional working with advanced equipment in a controlled laboratory environment, illustrating China medical device imports, regulatory compliance, product registration, quality management systems, and stable market access conditions in China.

Tuesday, 30, December, 2025 / Published in China, Medical Device, News

China Medical Device Imports Remain Stable in H1 2025

China’s medical device import market demonstrated continued stability in the first half of 2025, even as structural adjustments became more…

Healthcare professional reviewing diagnostic imaging equipment in a clinical setting, illustrating changes in China medical device procurement policies, value-based purchasing, regulatory reform, and compliance considerations for manufacturers entering the Chinese market.

Tuesday, 30, December, 2025 / Published in China, Medical Device, News

China Signals Shift Away From Price-Centric Criteria in Centralized Medical Device Procurement

At a State Council Information Office press briefing held on July 24, 2025, Chinese authorities outlined updated policy signals affecting…

Thursday, 27, November, 2025 / Published in China, Medical Device, News

China’s NMPA Releases Draft Adjustments to the IVD Classification Catalogue

China’s Center for Medical Device Standards Management under the National Medical Products Administration (NMPA) recently issued a public notice seeking…

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